The attorneys general of 38 states today reached a record-breaking agreement with AstraZeneca, which the states investigated for improper marketing practices. The states’ $68.5 million settlement resolves a three-year investigation into AstraZeneca Pharmaceutical’s efforts to market the antipsychotic drug Seroquel.
Today’s multistate agreement stems from a complaint in federal court charging AstraZeneca with unlawfully marketing Seroquel for unapproved – or off-label – uses. The states also charged AstraZeneca with failing to disclose Seroquel’s harmful side effects and concealing scientific data that revealed safety concerns.
Under the settlement, AstraZeneca agreed to comply with state and federal laws governing its marketing – including legal requirements that prohibit manufacturers from promoting their products for off-label uses not approved by the U.S. Food and Drug Administration (FDA).
While physicians may prescribe drugs for off-label uses, pharmaceutical manufacturers may not market their products for a purpose until that use has been approved by the FDA. AstraZeneca marketed Seroquel for a number of off-label purposes.
The states’ legal action explained that AstraZeneca targeted Alzheimer’s patients at nursing homes, as well as patients who suffered anxiety, depression, sleep disorders and post traumatic stress syndrome.
The settlement also imposes injunctive provisions that require AstraZeneca to:
• Publish any payments it makes to physicians on the
Internet;
• Implement policies that ensure its marketing and sales
personnel are not financially compensated for marketing off-label
uses;
• Establish polices to ensure that its sales personnel will
refrain from marketing Seroquel to health care providers who are
unlikely to prescribe it for an FDA-approved use; and
• Cite Seroquel’s FDA-approved indicators when
referencing selected symptoms.
Atypical antipsychotics, including Seroquel, can produce dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, an increased risk of mortality in elderly patients with dementia and other severe conditions.
